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A Multi-Center Group to Study Acute Liver Failure in Children

This study has been completed.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pittsburgh Identifier:
First received: September 29, 2009
Last updated: January 11, 2016
Last verified: January 2016
The PALF study group began with 20 sites and now continues with 12 sites (11 in the United States and 1 in Canada) in the new funding period. The primary objective of the Pediatric Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with ALF, including information derived from biospecimens.

Acute Liver Failure
Hepatic Encephalopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center Group to Study Acute Liver Failure in Children

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA
whole blood, serum, tissue

Enrollment: 158
Study Start Date: January 2000
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:
The PALF study group will collect clinical, epidemiological and outcome data on children with ALF. This information will be used to develop methods to predict whether a child will recover from the illness without the need for a liver transplant or other life-saving procedure. We believe the methods to predict survival will vary with different patient age groups, but that diagnosis, multi-system organ failure, degree of encephalopathy and level of coagulopathy will be important regardless of patient age. Biological samples, such as blood and liver tissue, will provide opportunities to identify subgroups of patients who have unique treatment requirements and outcomes. In addition, we hope to identify unrecognized mechanisms of liver injury resulting in ALF in children. Eligible study participants will be invited to participate in neurocognitive testing. Since patients that develop acute liver failure experience varying levels of hepatic encephalopathy and cerebral edema, we suspect that there may be residual sub-clinical neurological injury that compromises long-term neurocognitive function. Detailed neurocognitive testing has never been performed in a cohort of children that survive acute liver failure and this study seeks to close that information gap by defining the spectrum of neurocognitive outcomes in this population.

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children between birth and age 18 years who present with acute liver failure.

Inclusion Criteria:

  • Written informed consent/assent
  • Birth through 17 years of age
  • Biochemical evidence of acute liver injury
  • Coagulopathy not corrected by vitamin K (or other intervention intended to correct coagulopathy)

    • The presence of encephalopathy (ENC) is required if the INR is at least 1.5 and less than 2.0
    • If INR is at least 2.0, the presence of ENC is not required

Exclusion Criteria:

  • Known chronic underlying liver disease
  • Multi-organ system failure following heart surgery or ECMO
  • Solid organ or bone marrow transplantation
  • Acute trauma
  • Previously enrolled in the PALF Cohort Study
  • Other severe illness, condition, or other reason in the opinion of the investigator that would make the patient unsuitable for the study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00986648

  Show 20 Study Locations
Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Robert H Squires, MD Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh
  More Information


Responsible Party: University of Pittsburgh Identifier: NCT00986648     History of Changes
Other Study ID Numbers: 1U01DK072146-01 ( US NIH Grant/Contract Award Number )
U01DK072146 ( US NIH Grant/Contract Award Number )
2U01DK072146-06 ( US NIH Grant/Contract Award Number )
Study First Received: September 29, 2009
Last Updated: January 11, 2016

Keywords provided by University of Pittsburgh:
acute liver failure
hepatic encephalopathy
acetaminophen toxicity

Additional relevant MeSH terms:
Brain Diseases
Liver Failure
Hepatic Encephalopathy
Liver Failure, Acute
Central Nervous System Diseases
Nervous System Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases processed this record on April 21, 2017